/ Hiring

100533 Qc Assoc I

Who We Are

At the Roche Group, about 80,000 people across 150 countries are pushing back the frontiers of healthcare. Working together, we've become one of the world's leading research-focused healthcare groups. A member of the Roche Group, Genentech has been at the forefront of the biotechnology industry for more than 30 years, using human genetic information to develop novel medicines for serious and life-threatening diseases. The headquarters for Roche pharmaceutical operations in the United States, Genentech has multiple therapies on the market for cancer and other serious illnesses. Please take this opportunity to learn about Genentech, where we believe that our employees are our most important asset and are dedicated to remaining a great place to work.

The Position

Job Summary:

Perform analytical, biochemical testing and related activities to support QC operations

 

Description:

Must have flexible schedule, 4x10 day shift schedule. This role will require working major holidays.

Perform analytical, biochemical, and/or biological cell based testing of commercial and clinical in-process, drug substance, drug product and stability samples to meet standard lead times to support Quality Control Bioanalytical  / In-Process operations. 

Technical Duties/Responsibilities:
•Perform testing of routine and non-routine samples (e.g. Spectrophotometry, pH, HPLC) and document according to GMP.
•Review data and assess against established acceptance criteria
•Perform technical review of peer-generated data for basic methods
•Prepare data tables and graphs
•Identify discrepancies, participate in quality investigations and CAPA (corrective actions preventive actions) initiatives as needed.
•Receive and provide training
•Participate in assay transfer and assay validation.
•Perform equipment qualification / maintenance
•Prepare and maintain standards, controls, stocks, and cultures per established procedures
•Support the maintenance and compliance of operational areas.
•Assure and apply GMP throughout operations.
•Coordinate with customers to support operational activities.
•Support internal and external audits.
•Work to meet schedules.
•Identify and support resolution of technical problems.
•Actively participate in group and project teamwork; project and process improvements.
•Drafts protocols and reports under supervision.
•Meets scheduled performance of 95% on time.
•Perform other duties as requested by managers to support Quality activities.

Note:
•Position may involve use of reagents and other chemical compounds, including but not limited to acetonitrile, chlorine, acids and bases, biologic toxins, microorganisms and potent compounds.
•Must be able to lift up to 10 lbs
•Repetitive pipeting

Who You Are

Minimum Requirements:
•B.S./B.A. degree.
•Degree preferably in relevant scientific discipline.
•Experience with GMPs and quality control in pharmaceutical or biopharmaceutical industry.
•Strong verbal and written communication skills, ability to organize and present information both formally and informally.
•Demonstrated ability to apply knowledge of scientific theories, principles, and techniques used in analytical or biological test procedures.
•Routinely exercises sound judgment, reasoning and problem solving.
•Capable of working under moderate supervision, determining own short term priorities and working with or leading a team.

The next step is yours. To apply today, click on the "Apply online" button below.

Genentech is an Equal Opportunity Employer.